Assessing the Performance of a Novel Stool-Based Microbiome Test That Predicts Response to First Line Immune Checkpoint Inhibitors in Multiple Cancer Types
Abstract
:Simple Summary
Abstract
1. Introduction
2. Materials and Methods
2.1. Patients and Inclusion/Exclusion Criteria
2.2. Study Design and Treatments
2.3. Questionnaire Data
2.4. Sample Collection
2.5. DNA Extraction and Sequencing
2.6. Bioinformatic Analysis
2.7. BiomeOne® Response Prediction
2.8. Statistical Analyses
3. Results
3.1. Patients’ Demographics
3.2. Longitudinal Influence of ICI Treatment on the Intestinal Microbiome
3.3. Prediction of Clinical Outcome of ICI Therapy Using the Stool-Based Microbiome Test BiomeOne® at Baseline
3.4. Baseline Compositional Differences May Drive Clinical Response
3.5. BiomeOne® Exhibited Higher Sensitivity in Predicting Response Than the PD-L1 Expression Test
3.6. Occurrence/Severity of irAEs Depends Heavily on the Baseline Intestinal Microbiome Composition
4. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Total (n = 65) | R (n = 43) | NR (n = 22) | p-Value | ||
---|---|---|---|---|---|
Sex | |||||
Male | 38 (58.46) | 24 (55.81) | 14 (63.64) | 0.60 | |
Female | 27 (41.54) | 19 (44.19) | 8 (36.36) | ||
Age (mean ± SD, years) | 66.57 ± 8.78 | 65.38 ± 8.69 | 68.91 ± 8.67 | 0.12 | |
Cancer type | |||||
NSCLC | Stage III | 11 (16.92) | 10 (23.26) | 1 (4.54) | 0.07 |
Stage IV | 31 (47.69) | 21 (48.84) | 10 (45.45) | ||
RCC | Stage III | 4 (6.15) | 3 (6.98) | 1 (4.54) | |
Stage IV | 12 (18.46) | 7 (16.28) | 5 (22.73) | ||
Melanoma | Stage III | 0 (0.00) | 0 (0.00) | 0 (0.00) | |
Stage IV | 7 (10.77) | 2 (4.65) | 5 (22.73) | ||
Treatment | |||||
Anti-PD-1/PD-L1 | 62 (95.38) | 43 (100.00) | 19 (86.36) | 0.04 | |
Anti-PD-1/CTLA-4 | 3 (4.62) | 0 (0.00) | 3 (13.64) | ||
irAEs | |||||
No | 21 (32.31) | 20 (46.51) | 1 (4.55) | <0.01 | |
Yes (≥grade 1) | 44 (67.69) | 23 (53.49) | 21 (95.45) |
Rs (CR + PR) | NRs (SD + PD) | Total | |
---|---|---|---|
BiomeOne result > 50% | 34 | 10 | 44 |
BiomeOne result ≤ 50% | 8 | 11 | 19 |
Total | 42 | 21 | 63 |
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Robinson, I.; Hochmair, M.J.; Schmidinger, M.; Absenger, G.; Pichler, M.; Nguyen, V.A.; Richtig, E.; Rainer, B.M.; Ay, L.; Jansen, C.; et al. Assessing the Performance of a Novel Stool-Based Microbiome Test That Predicts Response to First Line Immune Checkpoint Inhibitors in Multiple Cancer Types. Cancers 2023, 15, 3268. https://doi.org/10.3390/cancers15133268
Robinson I, Hochmair MJ, Schmidinger M, Absenger G, Pichler M, Nguyen VA, Richtig E, Rainer BM, Ay L, Jansen C, et al. Assessing the Performance of a Novel Stool-Based Microbiome Test That Predicts Response to First Line Immune Checkpoint Inhibitors in Multiple Cancer Types. Cancers. 2023; 15(13):3268. https://doi.org/10.3390/cancers15133268
Chicago/Turabian StyleRobinson, Irina, Maximilian Johannes Hochmair, Manuela Schmidinger, Gudrun Absenger, Martin Pichler, Van Anh Nguyen, Erika Richtig, Barbara Margaretha Rainer, Leyla Ay, Christian Jansen, and et al. 2023. "Assessing the Performance of a Novel Stool-Based Microbiome Test That Predicts Response to First Line Immune Checkpoint Inhibitors in Multiple Cancer Types" Cancers 15, no. 13: 3268. https://doi.org/10.3390/cancers15133268